MAUDE Adverse Event Report: ABBOTT GERMANY ALINITY C CALCIUM

Catalog Number 07P57-20

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely depressed calcium result on the alinity analyzer.The following data was provided for a (b)(6) male patient: sid (b)(6): initial 1.346, repeats 2.693, 2.184 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

The sample gave error messages 3022 unable to process test due to previous aspiration error on sample and 3430 unable to process test, sample aspiration error.Because of these errors, the sample was inspected and found to have a clot.The clot was removed and the sample was retested giving the same error message.The sample was recentrifuged several times and the clots removed, finally generating calcium results of 2.693 mmol/l and 2.184 mmol/l.Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within expected limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ALINITY C CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 8744494
• MDR Text Key: 149705802
• Report Number: 3002809144-2019-00387
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2019
• Device Catalogue Number: 07P57-20
• Device Lot Number: 63032UN18
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C ANALYZER.; ALINITY C ANALYZER.; LN 03R67-01 SN (B)(4).; LN 03R67-01 SN (B)(4).
• Patient Age: 47 YR